Abstract
Introduction:
Surgical innovation is important to advance care for patients. There are, however, challenges for high- quality patient-centred communication due to inconsistent and incomplete information disclosure during consultations involving surgical innovation.1 There is a need to support shared decision making(SDM) and optimise informed consent in this context. This study developed a core information set(CIS) that will facilitate consultations between health professionals and patients offered novel surgical procedures/devices.
Methods:
This study adhered to guidance for CIS development2 and core outcome set development (COS- STAD).3 There were three phases: (1) generation of a provisional core information set from multiple data sources (44 interviews with patients/professionals, 34 recorded consultations, 213 published studies, 58 policy documents) applying thematic content analysis, (2) refinement and agreement of the CIS with stakeholders (patient representatives, surgeon innovators, anaesthetists, lawyers, ethicists, medical directors, academic experts in SDM, regulatory body representatives) using modified nominal group technique, (3) public consultation in the United Kingdom.
Results:
Phase 1: Eight initial themes and 28 subthemes were generated from the 349 data sources. Phase 2: 25 stakeholders refined and agreed seven themes in the final CIS to cover what is ‘new’ about the procedure, conflicts of interest, reasons for the innovation, treatment alternatives, unknowns, expertise with the innovation, and governance, oversight, and accountability. Phase 3: 136 public consultation participants endorsed all themes.
Discussion:
The CIS provides baseline information for consultations between health professionals and patients being offered novel surgical procedures/devices to achieve transparent/consistent information provision.
It can be applied flexibly within established processes of SDM to catalyse personalised discussions and address current deficiencies in informed consent.
Conclusion(s):
An evidence-based CIS has been co-developed with key stakeholders and is the recommend standard to optimise SDM and informed consent for surgical innovation.
Surgical innovation is important to advance care for patients. There are, however, challenges for high- quality patient-centred communication due to inconsistent and incomplete information disclosure during consultations involving surgical innovation.1 There is a need to support shared decision making(SDM) and optimise informed consent in this context. This study developed a core information set(CIS) that will facilitate consultations between health professionals and patients offered novel surgical procedures/devices.
Methods:
This study adhered to guidance for CIS development2 and core outcome set development (COS- STAD).3 There were three phases: (1) generation of a provisional core information set from multiple data sources (44 interviews with patients/professionals, 34 recorded consultations, 213 published studies, 58 policy documents) applying thematic content analysis, (2) refinement and agreement of the CIS with stakeholders (patient representatives, surgeon innovators, anaesthetists, lawyers, ethicists, medical directors, academic experts in SDM, regulatory body representatives) using modified nominal group technique, (3) public consultation in the United Kingdom.
Results:
Phase 1: Eight initial themes and 28 subthemes were generated from the 349 data sources. Phase 2: 25 stakeholders refined and agreed seven themes in the final CIS to cover what is ‘new’ about the procedure, conflicts of interest, reasons for the innovation, treatment alternatives, unknowns, expertise with the innovation, and governance, oversight, and accountability. Phase 3: 136 public consultation participants endorsed all themes.
Discussion:
The CIS provides baseline information for consultations between health professionals and patients being offered novel surgical procedures/devices to achieve transparent/consistent information provision.
It can be applied flexibly within established processes of SDM to catalyse personalised discussions and address current deficiencies in informed consent.
Conclusion(s):
An evidence-based CIS has been co-developed with key stakeholders and is the recommend standard to optimise SDM and informed consent for surgical innovation.
| Original language | English |
|---|---|
| DOIs | |
| Publication status | Published - 10 Jul 2024 |
| Event | 12th International Shared Decision Making Conference 2024 (ISDM 2024) - Lausanne, Switzerland Duration: 7 Jul 2024 → 10 Jul 2024 https://unisante-events.com/isdm2024/ |
Conference
| Conference | 12th International Shared Decision Making Conference 2024 (ISDM 2024) |
|---|---|
| Abbreviated title | ISDM2024 |
| Country/Territory | Switzerland |
| City | Lausanne |
| Period | 7/07/24 → 10/07/24 |
| Internet address |
Bibliographical note
Publisher Copyright:© Author(s) (or their employer(s)) 2024. No commercial re-use. See rights and permissions. Published by BMJ.
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